History of Changes for Study: NCT03275103

Dose-Escalation Study of BFCR4350A in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)

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Study Record Versions

Version	Submitted Date	Changes
1	September 5, 2017	None (earliest Version on record)
2	November 3, 2017	Study Status
3	December 1, 2017	Study Status and Contacts/Locations
4	January 3, 2018	Contacts/Locations and Study Status
5	February 12, 2018	Study Status
6	March 20, 2018	Study Status and Contacts/Locations
7	April 24, 2018	Study Status and Contacts/Locations
8	May 30, 2018	Study Status
9	June 21, 2018	Study Status and Contacts/Locations
10	July 30, 2018	Study Status and Contacts/Locations
11	August 17, 2018	Study Status
12	September 20, 2018	Study Status
13	October 29, 2018	Study Status
14	November 28, 2018	Study Status
15	January 9, 2019	Study Status
16	February 8, 2019	Study Status and Eligibility
17	March 28, 2019	Study Status
18	April 25, 2019	Study Status
19	June 1, 2019	Study Status
20	July 2, 2019	Study Status
21	August 22, 2019	Study Status
22	September 18, 2019	Arms and Interventions, Study Status, Contacts/Locations and Study Design
23	October 31, 2019	Study Status
24	December 31, 2019	Study Status
25	January 31, 2020	Study Status
26	February 27, 2020	Study Status
27	March 27, 2020	Study Status
28	April 23, 2020	Study Status
29	May 20, 2020	Study Status
30	June 15, 2020	Study Status
31	July 15, 2020	Study Status
32	August 13, 2020	Study Status and Contacts/Locations
33	September 11, 2020	Contacts/Locations and Study Status
34	October 13, 2020	Study Status and Contacts/Locations
35	November 18, 2020	Arms and Interventions, Outcome Measures, Study Status, Contacts/Locations, Eligibility and Study Design
36	December 18, 2020	Study Status and Contacts/Locations
37	January 18, 2021	Study Status
38	February 16, 2021	Study Status and Study Identification
39	March 15, 2021	Study Status
40	April 12, 2021	Arms and Interventions, Outcome Measures, Study Status, Study Identification, Eligibility and Study Description
41	May 7, 2021	Study Status and Contacts/Locations
42	June 4, 2021	Study Status
43	July 29, 2021	Study Status
44	August 25, 2021	Study Status and Contacts/Locations
45	September 23, 2021	Study Status
46	October 22, 2021	Study Status and Contacts/Locations
47	November 16, 2021	Study Status
48	December 14, 2021	Study Status
49	January 12, 2022	Study Status
50	February 8, 2022	Study Status
51	March 2, 2022	Study Status
52	March 30, 2022	Outcome Measures, Arms and Interventions, Study Status, IPDSharing, Eligibility and Study Design
53	April 25, 2022	Study Status
54	May 20, 2022	Study Status
55	June 20, 2022	Contacts/Locations and Study Status
56	July 20, 2022	Study Status
57	August 17, 2022	Study Status
58	September 14, 2022	Study Status
59	October 7, 2022	Study Status, Outcome Measures, Arms and Interventions, Eligibility and Study Design
60	January 23, 2023	Study Status
61	February 17, 2023	Study Status and Contacts/Locations
62	April 11, 2023	Study Status
63	May 18, 2023	Study Status, Eligibility and Study Identification
64	June 14, 2023	Study Status
65	July 7, 2023	Study Status
66	August 4, 2023	Study Status
67	September 1, 2023	Study Status
68	October 3, 2023	Study Status
69	November 1, 2023	Study Status
70	December 15, 2023	Study Status
71	January 12, 2024	Study Status
72	February 8, 2024	Study Status
73	March 5, 2024	Study Status
74	April 3, 2024	Study Status and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	GO39775
Brief Title:	Dose-Escalation Study of BFCR4350A in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
Official Title:	An Open-Label, Multicenter, Phase I Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of BFCR4350A in Patients With Relapsed or Refractory Multiple Myeloma
Secondary IDs:

Study Status


Record Verification:	August 2017
Overall Status:	Recruiting
Study Start:	September 15, 2017
Primary Completion:	June 1, 2021 [Anticipated]
Study Completion:	June 1, 2021 [Anticipated]

First Submitted:	September 5, 2017
First Submitted that Met QC Criteria:	September 5, 2017
First Posted:	September 7, 2017 [Actual]

Last Update Submitted that Met QC Criteria:	September 5, 2017
Last Update Posted:	September 7, 2017 [Actual]

Sponsor/Collaborators


Sponsor:	Genentech, Inc.
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description


Brief Summary:	This is a phase I, multicenter, open-label, dose-escalation study of BFCR4350A administered as a single agent by IV infusion to participants with relapsed or refractory multiple myeloma (R/R MM).
Detailed Description:

Conditions


Conditions:	Multiple Myeloma
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Single Group Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	80 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

Experimental: Dose Escalation for BFCR4350A

Study drug will be administered intravenously on a 21-day cycle. Initially, cohorts will consist of 1 participant each. Subsequently will consist of at least 3 participants, unless dose-limiting toxicities (DLTs) are observed in the first 2 prior to enrollment of a third participant. For each cohort, treatment with the first dose will be staggered such that the second participant enrolled in the cohort will receive study drug at least 72 hours after the first participant receives it to allow assessment of any severe and unexpected acute or subacute drug or infusion-related toxicities; dosing in subsequent participants in each cohort will be staggered by at least 24 hours.

Drug: BFCR4350A

BFCR4350A will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.

Other Names:

RO7187797

Experimental: Expansion Phase for BFCR4350A

Participants exhibiting acceptable safety and evidence of clinical benefit will be administered study drug every 21 days up to a maximum of 17 cycles until objective disease progression is documented or unacceptable toxicity, whichever occurs first.

Drug: BFCR4350A

BFCR4350A will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.

Other Names:

RO7187797

Outcome Measures


Primary Outcome Measures:
1.	Incidence and Severity of Adverse Events (AEs) [ Time Frame: Up to approximately 3 years ] An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.
Secondary Outcome Measures:
1.	Cmax [ Time Frame: Up to approximately 3 years ] Defined as the maximum observed serum concentration of study drug.
2.	Objective Response Rate (ORR) [ Time Frame: Up to approximately 3 years ] OR is defined as percentage of participants with partial response (PR) or complete response (CR). CR is defined as no evidence of initial monoclonal protein isotype(s) on immunofixation of the serum and urine, disappearance of any soft tissue plasmacytomas, and </= 5% plasma cells in bone marrow (BM). PR is defined as >/= 50% reduction of serum M-protein and reduction in 24-hour urine M-protein by >/= 90% or to < 200 milligrams (mg)/24 hours.
3.	Duration of Response [ Time Frame: Up to approximately 3 years ] Time from first occurrence of OR (defined previously) to disease progression (PD) or death from any cause. PD: increase of >/=25% from lowest response value in one of the following: serum M-protein (absolute increase >/=0.5 grams per deciliter (g/dL); serum M-protein increase >/=1g/dL, if lowest M component was >/=5g/dL; urine M-protein (absolute increase >/=200 mg/24 hours); no measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase >10 mg/dL); no measurable serum and urine M-protein levels and no measurable disease by FLC: BM plasma cell % irrespective of baseline status (absolute % >/=10%); new lesion(s) >/=50% increase from lowest point in sum of the products of diameters of > 1 lesion, or >/=50% increase in longest diameter of a previous lesion >1 centimeter (cm) in short axis; >/=50% increase in circulating plasma cells (minimum 200 cells per microliter) if only measure of disease.
4.	Change from Baseline in the Presence Anti-Drug Antibodies (ADAs) [ Time Frame: Up to approximately 3 years ] To evaluate the immune response to the study drug.
5.	Minimum observed serum concentration (Cmin) [ Time Frame: Up to approximately 3 years ] Defined as the minimum observed serum concentration of study drug.
6.	Area Under the Concentration-Time Curve [ Time Frame: Up to approximately 3 years ] Defined as the total exposure of study drug.
7.	Clearance (CL) [ Time Frame: Up to approximately 3 years ] Defined as the volume of plasma cleared of the drug per unit time.
8.	Volume of Distribution at Steady State (Vdss) [ Time Frame: Up to approximately 3 years ] Defined as the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Life expectancy of at least 12 weeks Participants must have relapsed or refractory (R/R) multiple myeloma (MM) for which no established therapy for MM is appropriate and available or be intolerant to those established therapies Adverse events from prior anti-cancer therapy resolved to Grade < or = 1, except any grade alopecia and/or peripheral sensory or motor neuropathy which must have resolved to Grade < or = 2 Measurable disease defined by laboratory test results Female participants of childbearing age must agree to remain abstinent or use reliable contraceptive methods during the treatment period, and at least 3 months after last dose of study drug Male participants must agree to refrain from donating sperm, to abstain or use a condom during the treatment period, and at least 60 days after last dose of study drug Exclusion Criteria: Inability to comply with protocol-mandated hospitalization and activities restrictions Pregnant, lactating, or planning to become pregnant during the study and up to 3 months after last dose of study drug Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate within 4 weeks before first infusion Prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first infusion Treatment-related, immune-mediated adverse events associated with prior immunotherapeutic agents Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first BFCR4350A infusion Autologous stem cell transplantation (SCT) within 100 days prior to first infusion Prior allogeneic SCT or solid organ transplantation Primary or secondary plasma cell leukemia History of autoimmune disease or of confirmed progressive multifocal leukoencephalopathy History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) History of other malignancy that could affect compliance with the protocol or interpretation of results Current or past history of central nervous system (CNS) disease, or CNS involvement by MM Significant cardiovascular disease or active pulmonary disease Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks prior to first infusion Known or suspected chronic active Epstein-Barr virus (EBV) infection, acute or chronic hepatitis C virus (HCV) infection Positive serologic or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection Recent major surgery within 4 weeks prior to first infusion Human Immunodeficiency Virus (HIV) positive History of illicit drug or alcohol abuse within 12 months prior to screening Any medical condition or laboratory test abnormality that precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results

Contacts/Locations


Central Contact Person:	Reference Study ID Number: GO39775 www.roche.com/about_roche/roche_worldwide.htm Telephone: 888-662-6728 (U.S. only) Email: global-roche-genentech-trials@gene.com
Study Officials:	Clinical Trials Study Director Genentech, Inc.
Locations:	United States, Arizona
	Mayo Clinic Hospital - Arizona [Not yet recruiting] Scottsdale, Arizona, United States, 85259
	United States, California
	City of Hope [Recruiting] Duarte, California, United States, 91010
	United States, Colorado
	University of Colorado Denver [Not yet recruiting] Aurora, Colorado, United States, 80045
	United States, Massachusetts
	Dana Farber Cancer Institute [Not yet recruiting] Boston, Massachusetts, United States, 02215
	United States, Pennsylvania
	University of Pennsylvania [Not yet recruiting] Philadelphia, Pennsylvania, United States, 19104
	United States, Tennessee
	Sarah Cannon Research Institute [Recruiting] Nashville, Tennessee, United States, 37203
	Australia, Victoria
	Peter MacCallum Cancer Center [Not yet recruiting] Melbourne, Victoria, Australia, 3000
	Alfred Hospital [Not yet recruiting] Melbourne, Victoria, Australia, 3004
	Canada, Ontario
	Princess Margaret Cancer Center [Not yet recruiting] Toronto, Ontario, Canada, M5G 1Z6

IPDSharing


Plan to Share IPD:

References


Citations:
Links:
Available IPD/Information: